European survey underscores migraine burden

Main Category: Headache / Migraine
Article Date: 21 Sep 2005 - 0:00 PDT

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European Federation of Neurological Societies (EFNS) meeting 17-20 September 2005, Athens, Greece.

Half of all migraine sufferers are incapacitated during a migraine attack leaving them feeling socially isolated, guilty and dependant, according to results from a pan-European patient survey presented at this week's meeting of the European Federation Neurological Societies (EFNS) meeting, Athens, Greece.

The 'Migraine Experience' survey (1) analysed the impact of migraine on the lives of 2,061 sufferers from the UK, France, Spain, Italy, Germany, Switzerland, Sweden, Finland, Norway and Denmark.

According to the results, 69 per cent of migraine sufferers say that migraine makes them feel left out of every day life and half said their migraine makes them feel miserable, helpless, frustrated, stressed and defeated. 81 per cent reported that their social life comes to a halt with a migraine attack and 54 per cent said it impacts on their ability to take care of family or children.

The survey also found that migraine sufferers feel their attacks decrease their productivity, with 75 per cent of respondents claiming migraines negatively affect their performance at work or school. Nearly a quarter of respondents feel their career progression has been affected by their condition.

Ann Turner, Director of the Migraine Action Association in the UK says "These results highlight the considerable lack of understanding the general public have about migraine. It is imperative that we continue to increase awareness so that people with the condition are no longer isolated in society and are able to enjoy an improved quality of life instead of suffering in silence."

Despite recent progress in migraine management and new treatments available, many patients still feel that their migraine is not effectively managed and that there remains a substantial need for a better public and professional understanding of the condition. The survey results support this feeling, highlighted by the fact over half of respondents (53 per cent) stated they would like to live without the constant worry of another migraine attack and 69 per cent were interested in a daily preventative medication to stop migraine attacks from occurring.

"Migraine can be seriously debilitating, with a huge impact on daily activities that most people simply take for granted. For some migraineurs with frequent and disabling migraines, preventative medication can help them to regain some control over their condition," commented Dr Anne MacGregor, City of London Migraine Clinic.

Preventing migraine attacks

Results from two clinical trials presented at the Athens meeting demonstrate that patients with frequent migraine who were treated with Topamax (topiramate) for up to 14 months (6 months double blind followed by 8 months open label) showed a persistent reduction in the frequency of migraine headaches (2). In addition, analyses from the three 26-week placebo-controlled pivotal trials of topiramate in migraine prevention showed that topiramate improves health-related quality of life (HRQoL)(3).

Efficacy and tolerability results presented from the 8 month open-label extension (OLE) phases of two pivotal, 6-month, randomised, double-blind (DB), placebo-controlled trials with topiramate, demonstrated a persistent reduction in monthly migraine frequency that was consistent with the initial 6-month maintenance period (100mg/d topiramate change from baseline; -2.5 by end of DB phase, and -3.7 by end of OLE phase).

A separate analysis of the three pivotal, 26-week, randomised, double-blind, migraine prevention trials with topiramate showed that 100 mg/d significantly improved health-related quality of life for patients with migraine for up to six months following initiation of treatment (3).

Dr Domenico D'Amico from the Neurological Institute C. Besta in Milan (Italy), commented: "While acute treatments can lessen the symptoms of a migraine attack once it has started, these trials show that using topiramate as preventative therapy reduces the frequency of migraine attacks. These results offer new hope for patients with frequent migraine in terms of controlling their condition and bring them one step closer to leading a normal, healthy life."

The most common side effects experienced by patients taking 100 mg of topiramate included paresthesia (mild tingling sensations in the extremities), loss of appetite, fatigue, nausea, taste alteration, diarrhoea, cognitive side effects and weight loss. The most common adverse events leading to drug discontinuation were fatigue (1.8%), paresthesia (1.6%) and language problems (1.6%). When these side effects occurred, most were mild to moderate in severity and resolved once the medication was discontinued.

Professor Hans-Christoph Diener, Department of Neurology, University of Essen, Germany, said that pooled analyses indicate that 6 per cent of patients treated with topiramate become migraine free, which he described as a 'major achievement'. "Furthermore, some 20% of patients experience a reduction of more than 75% in migraine attack frequency, so about one fifth of patients have a dramatic reduction in migraine frequency, this really is clinically meaningful for patients."

"This drug is not without side effects - however an interesting side effect is loss of appetite and loss of weight. This [topiramate] is the only preventive drug that leads to loss of weight or to weight being unchanged. All other preventive therapies lead to weight gain, which can be a major problem for our female patients."

Treating pain of 'suicide headache'

Rapid relief from the debilitating pain of cluster headache - often so excruciating it is known as 'suicide headache' - can be achieved using zolmitriptan ('Zomig') nasal spray, according to data presented at the EFNS meeting (4).

A study by Dr Peter Goadsby, Institute of Neurology, Queen Square, London, and colleagues, showed that zolmitriptan nasal spray achieved the primary endpoint of headache relief at 30 minutes with significantly higher response compared to placebo (60% zolmitriptan 10mg, 38% zolmitriptan 5mg vs. 21% placebo; p<0.001).

The study, conducted at five sites in Germany, Italy and the UK, the study enrolled ninety-two patients, 80 males and 12 females, with a mean age of 42 (ranging from 24 to 61), who suffered from either episodic cluster headache or chronic cluster headache. Patients were randomised into a placebo-controlled, double-blind study protocol. Three attacks were treated with placebo, zolmitriptan 5mg or zolmitriptan 10mg.

Headache relief at 30 minutes was significantly higher for the 10mg and 5mg formulations in episodic cluster headache, compared to placebo: 80% and 47% vs. 24% (p<0.001), as well as in chronic cluster headache, compared to placebo: 38% and 27% vs. 17% (p<0.001). Headache relief was superior to placebo from as early as 5 minutes and at every five minute interval up to 30 minutes.

Dr Goadsby, lead investigator of the study, commented, "These results are highly significant when facing the dilemma of how to treat this debilitating type of primary headache disorder. Cluster headache attacks are rapid in onset and patients suffer excruciating pain. Current treatments include injection of sumatriptan or inhalation of oxygen, but the fact that zolmitriptan nasal spray has proved effective and well tolerated in cluster headache offers physicians and patients an extremely acceptable alternative for fast-acting reliable relief."

Secondary endpoints of the study included pain-free rate and associated symptom relief (nasal congestion, facial sweating, restlessness and agitation), as well as tolerability compared to placebo. No serious adverse events were reported in either the placebo or zolmitriptan treated groups.

A spokesman for manufacturers AstraZeneca, said that the company would be discussing the new data with licensing authorities.

Report by Ian Mason
Medical Journalist, Telephone +44 1932 40051
ianmason@ntlworld.com
References

(1) Turner A. 'Patients' attitude towards treatment of migraine - Results from a large EU Survey in Migraine Sufferers. EFNS Congress 2005 Abstract P2131

(2) Diener H C et al. Long-Term Effectiveness of Topiramate for Migraine Prevention: Analyses of Open-Label Extension-Phase Data from Two Pivotal Studies. EFNS Congress 2005 Abstract P2138.

(3) Dahlöf C et al. Analyses of Quality of Life Indicators from 3 Placebo-Controlled Trials of Topiramate for Migraine Prevention. EFNS Congress 2005 Abstract P1158.

(4) Cittadini E & Goadsby P et al. Zolmitriptan nasal spray is effective and well tolerated in the acute treatment of cluster headache: a double-blind placebo-controlled crossover study. EFNS 2005 Abstract P2140

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